Pharmaceutical balance tipping to specialty side

The new world of targeted, specialized medicines — many of them bioengineered and many of them aimed at smaller and smaller segments of the population — isn’t just on its way. It’s here. And it’s going to radically change the practice of pharmacy.

Here’s an eye-opener: Specialty drugs will likely account for 50% of all drug costs by 2018, up from 28.7% of total prescription drug costs in 2012.

That’s according to two new studies from pharmacy benefit manager Prime Therapeutics and Blue Cross and Blue Shield of Minnesota. As reported in Drug Store News, April 2, the studies were based on pharmacy and medical claims from 1.2 million commercially insured and continuously enrolled members receiving a drug for hepatitis C or rheumatoid arthritis, and looked at cost-of-care trends for the two disease states.

Specialty drugs, said Sumit Dutta, SVP and chief medical officer for pharmacy benefit manager Catamaran Corp., are now “the primary driver of new product development, where you’ve got new therapies for narrower and narrower diseases.” As opposed to old-line drugs like broad-spectrum antibiotics or statins, he added, many of the new medicines are aimed at “a much smaller group of people in a targeted way.”

Still to come, said the physician, is “the promise of individualized therapies and personalized medicine."

“We’re not there yet but we’re moving toward that,” he predicted recently in an interview.

What will that mean for community, institutional and hospital pharmacy? Will pharmacies of the future be like therapeutic boutiques, where individual patients, pharmacists, physicians, nurse practitioners and other clinicians work in a virtual side-by-side setting, connected electronically and applying genomic research and molecular tinkering as they constantly fine-tune dosages and expensive drug formulations for maximum patient benefit?

One thing seems certain: pharmacists will be called on, more and more, to manage expensive and time-consuming specialty drug therapies for patients with serious, complex and chronic conditions. And in the process, they’ll be making a huge beneficial impact on millions of patients whose lives will depend on those medicines and pharmacist interventions.

FDA approves first new morning sickness pill in 30 years

ROSEMONT, Pa. — The Food and Drug Administration has approved a drug for treating nausea and vomiting during pregnancy.

Drug maker Duchesnay USA said the FDA approved Diclegis (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets in the 10 mg/10 mg strength for NVP, more commonly known as morning sickness, in women who don’t respond to conservative treatment. NVP is estimated to affect 70-85% of pregnant women, and symptoms range from nausea to severe vomiting and retching that can last throughout the day.

The company said Diclegis was the first FDA-approved treatment for morning sickness in more than 30 years.

"The FDA approval of Diclegis provides an important new treatment to the millions of women suffering from nausea and vomiting of pregnancy and fills a 30-year void in the treatment of NVP," Duchesnay CEO Gilbert Godin said. "Duchesnay USA is honored to bring the only FDA-approved treatment to help control symptoms of morning sickness to market."

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Patients taking AstraZeneca RA drug show partial improvement

NEW YORK — An experimental drug developed by AstraZeneca for rheumatoid arthritis produced mixed results in measurements of patients’ conditions, according to results of a late-stage clinical trial.

AstraZeneca announced initial results of the phase-3 "OSKIRA-1" trial of fostamatinib, which it calls the first oral spleen tyrosine kinase inhibitor in development for RA.

The goals of the study were to measure signs and symptoms of RA based on two measures, known as ACR20 and mTSS after 24 weeks of treatment. The ACR20 measure indicated statistically significant improvement in patients’ conditions compared with those who took placebo, while mTSS did not.

ACR20, which stands for American College of Rheumatology 20, means a patient has at least 20% fewer tender joints and at least 20% fewer swollen joints, as well as 20% improvement in various assessments of the patient’s condition. The mTSS, which stands for modified total sharp score, measures bone erosion and joint-space narrowing using X-rays.

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